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This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-450/r/ABT-267 plus RBV for 12 weeks | Experimental | ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks |
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| ABT-450/r/ABT-267 plus RBV for 16 weeks | Experimental | ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/r/ABT-267 | Drug | Tablet; ABT-450 coformulated with ritonavir and ABT-267 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. | 12 weeks after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasunori Yachi | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28536999 | Background | Sato K, Chayama K, Alves K, Toyoda H, Suzuki F, Kato K, Rodrigues L Jr, Zhang X, Setze C, Pilot-Matias T, Burroughs M, Redman R, Kumada H. Randomized Phase 3 Trial of Ombitasvir/Paritaprevir/Ritonavir and Ribavirin for Hepatitis C Virus Genotype 2-Infected Japanese Patients. Adv Ther. 2017 Jun;34(6):1449-1465. doi: 10.1007/s12325-017-0506-y. Epub 2017 May 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-450/r/ABT-267 Plus RBV for 12 Weeks | ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks |
| FG001 | ABT-450/r/ABT-267 Plus RBV for 16 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ribavirin | Drug | Capsule |
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| 12 or 16 weeks (end of treatment period) |
| Percentage of Participants With Post-treatment Relapse | Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm. | within 12 weeks after the last dose of study drug |
| Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis. | 12 weeks after last dose of study drug |
| Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations | The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment). | 12 or 16 weeks (end of treatment period) |
| Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm. | within 12 weeks after the last dose of study drug |
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-450/r/ABT-267 Plus RBV for 12 Weeks | ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks |
| BG001 | ABT-450/r/ABT-267 Plus RBV for 16 Weeks | ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. | Primary efficacy population: all treatment-naïve, noncirrhotic participants in the intent-to-treat (ITT) population (all randomized participants who received at least 1 dose of study drug). | Posted | Number | percentage of participants | 12 weeks after last dose of study drug |
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| Secondary | Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment). | Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug). | Posted | Number | percentage of participants | 12 or 16 weeks (end of treatment period) |
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| Secondary | Percentage of Participants With Post-treatment Relapse | Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm. | Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug) with HCV RNA < LLOQ at the final treatment visit who completed treatment. | Posted | Number | percentage of participants | within 12 weeks after the last dose of study drug |
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| Secondary | Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis. | ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
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| Secondary | Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations | The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment). | ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation. | Posted | Number | percentage of participants | 12 or 16 weeks (end of treatment period) |
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| Secondary | Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm. | ITT population: all randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment; n=participants in given subpopulation. | Posted | Number | percentage of participants | within 12 weeks after the last dose of study drug |
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Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic) | ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in non-cirrhotic participants | 0 | 80 | 52 | 80 | ||
| EG001 | ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic) | ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in non-cirrhotic participants | 3 | 80 | 53 | 80 | ||
| EG002 | ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic) | ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in cirrhotic participants | 0 | 5 | 3 | 5 | ||
| EG003 | ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic) | ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in cirrhotic participants | 0 | 6 | 4 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTRITIS ALCOHOLIC | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 17.0 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 17.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 17.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| BLOOD CHOLESTEROL DECREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| RED BLOOD CELL COUNT DECREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| RETICULOCYTE COUNT INCREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| HEAT ILLNESS | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| BLOOD URIC ACID INCREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| VITREOUS HAEMORRHAGE | Eye disorders | MedDRA 17.0 | Systematic Assessment |
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| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| POLLAKIURIA | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| URINARY RETENTION | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| HOT FLUSH | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| D019438 | Ritonavir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Title | Measurements |
|---|---|
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| Male |
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| Superiority or Other (legacy) |
| Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold. LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants. | percentage of participants with SVR12 | 75.0 | 2-Sided | 95 | 61.2 | 85.1 | Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold. | Superiority or Other (legacy) |
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